UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial for identifying the safety of the Ivermectin bath method.
Title of the study (Brief title)	The Ivermectin bath method
Region	Japan

Condition
Condition	scabies
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verifying the safety of Ivermectin bath method as a new treatment for scabies.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Monitoring the early symptoms of adverse effects of the Ivermectin bath method as its safety assessment.
Key secondary outcomes	Analysis of Ivermectin concentration in stratum corneum and blood after the use of Ivermectin bath method.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	As a preparation for the use of Ivermectin bath method, 4 tablets of Stromectol Tablets 3mg is dissolved in baby bath powder contained hot tub water of 150L. Then, one takes a bath in the prepared tub water. The second trial (same preparation as the first trial) is carried out after 7days. 22days of blank period for observation is implemented after the second trial.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- Patient diagnosed as scabies - Patient who belongs in a care service facility of a medical monitoring by specialized physician - Patient who signed, based on his/her free will, to the clinical trial agreement with full understanding of the purpose of this conducted trial and its insights.
Key exclusion criteria	1) Patient diagnosed with a skin disorder and thus has skin barrier problem 2) One who has had the experience of the following; - Hepatic disease - The disease considered to affect the test results by doctor in attendance. - The disease considered that use of Ivermectin results detrimental to the patient. 3) one with excessive consumption of caffeine contained coffee or drink (>8 cups / day) 4) abuser of medication or alcohol 5) The addict of an illegal drug 6) One who has contributed 200mL blood within 4 weeks before the trial, or male contributed 400mL blood within 12 weeks and female contributed 400mL blood within 16 weeks 7) One who participated in other clinical trials with the use of study medication within 4 weeks before the trial 8) One who has an anamnesis of hypersensitivity for the ingredients contained in Stromectol Tablets or in the baby bath powder (Pigeon, Inc.) 9) Pregnant female or lactating woman or child under 15kg weight 10) One whom the doctor considered to be unsuitable for this clinical trial
Target sample size	6

Research contact person
Name of lead principal investigator	Masayo Komoda
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
Address	2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL	04-7121-4134
Email	komo1207@rs.noda.tus.ac.jp

Public contact
Name of contact person	Masayo Komoda
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
Address	2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL	04-7121-4134
Homepage URL
Email	komo1207@rs.noda.tus.ac.jp

Sponsor
Institute	Laboratory of medical safety management, Tokyo University of Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tsubasa clinic
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 15 Day
Anticipated trial start date	2012 Year 09 Month 27 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 27 Day
Last modified on	2016 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010550